Severe sepsis is a major cause of morbidity and mortality throughout the world. It is the leading cause of death in non-coronary intensive care units (ICUs) in the United States, with more than 750,000 cases occurring every year. This means that in the United States, more than 500 patients die from severe sepsis every day, with 28% to 50% of the patients succumbing to the disease process at an average cost of $22,000 per patient. Successful development of TLF-based therapy for sepsis would satisfy a significant unmet medical need. Agennix has now established a manufacture of a pharmaceutical-grade talactoferrin, it has demonstrated its safety in clinical studies for various indications, and is now interacting with the FDA to obtain a go-ahead to initiate clinical Phase 3 studies in cancer. The development of talactoferrin is therefore at a stage that a demonstration of its clinical efficacy in sepsis would put the generation of a product to treat sepsis on a relatively easy and straightforward path.